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Clinical Trials/NCT05843539
NCT05843539
Completed
Not Applicable

Adverse Childhood Experiences, AdaPtatiOn and Breast Cancer

University of Lorraine1 site in 1 country100 target enrollmentApril 12, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adverse Childhood Experiences
Sponsor
University of Lorraine
Enrollment
100
Locations
1
Primary Endpoint
Quality of life of women in remission from breast cancer
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

Adverse Childhood Experiences (ACEs) have long been linked to mental health problems in adulthood. In the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. Activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. The attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. It is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. The fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. This is a determining factor in the occurrence of anxiety-depressive disorders. Finally, several studies have shown a strong association between depression/anxiety and Cancer-Related Fatigue (CRF) after treatment, especially during the remission phase.

ACEs leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. Life history changes are mediated by changes in cellular mechanisms affecting genome expression. It is currently widely demonstrated that ACEs increases epigenetic modifications.

The interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.

Registry
clinicaltrials.gov
Start Date
April 12, 2022
End Date
June 30, 2023
Last Updated
9 months ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
University of Lorraine
Responsible Party
Principal Investigator
Principal Investigator

Christine Rotonda

Director of the research pole in Pierre Janet Center

University of Lorraine

Eligibility Criteria

Inclusion Criteria

  • Have had breast cancer
  • Be considered in remission
  • Be over 18 years of age
  • Literate (able to understand the information and complete the questionnaire independently)
  • Agree to participate in the project and sign the informed consent form

Exclusion Criteria

  • Be a person subject to a legal protection measure
  • Be a protected adult, under guardianship or curators
  • Be undergoing oncological treatment
  • Have a lack of autonomy making it impossible to complete the questionnaire online
  • Have had or have begun psychotherapeutic treatment

Outcomes

Primary Outcomes

Quality of life of women in remission from breast cancer

Time Frame: Baseline. Through study completion, an average of 1 year.

The primary outcome was quality of life assessed with the Short Form Survey 12 (SF-12 scale). The score ranges from 0 to 100, with a score above 50 indicating average quality of life, 40 to 49 indicating mild disability, 30 to 39 indicating moderate disability, and below 30 indicating severe disability.

Secondary Outcomes

  • Attachment(Baseline. Through study completion, an average of 1 year.)
  • Anxiety and Depression(Baseline. Through study completion, an average of 1 year.)
  • Fear of recurrence(Baseline. Through study completion, an average of 1 year.)
  • Fatigue(Baseline. Through study completion, an average of 1 year.)
  • Adverse Childhood Experiences(Baseline. Through study completion, an average of 1 year.)
  • Resilience(Baseline. Through study completion, an average of 1 year.)
  • RMSSD values(Baseline. Through study completion, an average of 1 year.)

Study Sites (1)

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